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Re: flipper44 post# 505785

Wednesday, 08/17/2022 10:51:58 AM

Wednesday, August 17, 2022 10:51:58 AM

Post# of 822672

The pasted quote in your response is from you.



I know it is. Because I said it. Because I knew long ago you would eventually be changing your stance on the "MA will be submitted within 30 days bar no excuses" claim. And here we are, exactly what I said is happening.

It would be outrageous to think they are feigning intent to file an MAA before manufacturing cert decision.



Where has NWBO every made the claim that they intend to file an MAA before manufacturing cert decision? They haven't. They aren't feigning anything because they are making no such claims. That's just you.

If your point is simply you don’t have to file an MAA before manufacturing licensing decision is made, wherein the basis of application is a new product, I still say you are incorrect.



You do have to file an MA. I'm not arguing that. Our disagreement is which product MAA needs to be completed. You think it is DCVax-L MAA and DCVax-L alone that can grant Sawston/Advent the commercial license. My opinion is that because the license was submitted for the manufacture of any cell therapies, it is in fact the case that the existence of marketing approval for any cell therapies is enough to grant the license. It doesn't have to be DCVax specific.
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